Director, Pharmacometrician

Position Purpose

Provides pharmacometric expertise and leadership to projects.

Responsible for developing model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies inform drug development strategy and project decision-making in collaboration with partners.

Responsible and accountable for conducting and reporting quantitative analyses which integrate knowledge of pharmacokinetics pharmacodynamics patient characteristics and disease states to optimize doses dosage regimens and study designs throughout clinical drug development.

Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity efficacy and safety.

Acts as pharmacometric Subject Matter Expert (SME) including proactive support and development of quantitative methodology software automation hardware tools and related business processes in addition to training to the global clinical pharmacology organization.

Responsible for the pharmacometric leadership and support in preparation and defense of regulatory submissions.

Primary Duties

Contributes to MIDD complementary to Pfizer processes.

Responsible for the planning execution and reporting of relevant quantitative analyses which may include population pharmacokinetics pharmacokinetics/pharmacodynamics exposure response disease progression modeling model-based meta-analysis quantitative knowledge management decision analysis and MIDD strategy in collaboration with partners.

Responsible for the development and maintenance of automation tools improving the efficiency of pharmacometric analyses communications and decision making.

Prepares formal presentations and written reports to Pfizer standards.

Contributes with project teams/partners to regulatory responses briefing documents submissions or other regulatory documents and/or presentations.

Stays abreast of literature government guidelines and internal guidance as relates to pharmacometrics and MIDD including internal SOPs and regulations in order to be a team resource of pharmacometric knowledge and applications.

Contributes to Pharmacometrics ability to act as a conduit for cross learnings within/across the clinical development organizations. Promote educate and mentor others in application of quantitative techniques best practices MIDD and share experiences through appropriate local and global discussions.

Produces and presents quality scientific contributions at external meetings and for publication.

Responsible for contributions to and/or leading the development/improvement of our tools automations processes and methodology including involvement in internal cross-functional workgroups or initiatives external alliances or committees consortia and academic relationships.

May participate in and contribute to global computational sciences community of practice and contribute to business requirements/support of IT colleagues/contractors systems tools and data flow infrastructure to ensure support services to systems and software tools and colleagues are best in class. Produce and present quality scientific papers at external meetings and for publication.

Prepares and delivers training on quantitative tools methodologies software hardware and related business processes internally to Pharmacometricians and for the Translational Clinical Sciences organization.

May train develop and mentor less experienced Pharmacometricians or other clinical pharmacology colleagues.

May organize and manage project deliverables utilizing the appropriate expertise and resources (internally within the company and/or externally within consultant groups and academic institutions).

May participate in multidisciplinary teams in assessing potential in-licensing opportunities as requested by line management.

May collaborate with enable and influence external key opinion leaders and regulatory authorities in best practices for drug development science.

Training Education and Experience

At least 5 years of experience in pharmacostatistical modeling and application of MIDD.

An interest and experience of pharmacostatistical methods of data analysis and study design are essential.

Ideal qualifications include Pharm.D PhD or equivalent training or equivalent expertise in one or more areas related to pharmacostatistical modeling (e.g. pharmacometrics pharmacokinetics clinical pharmacology statistics or related discipline).

Candidates from alternative backgrounds (e.g. mathematics engineering system biology medicine) will be considered if they can demonstrate relevant experience and expertise.

Strong science and quantitative analysis background with good working knowledge of pharmacokinetics pharmacology pharmaceutics and/or statistics.

Basic understanding/knowledge of biology physiology/pathophysiology and drug research & development process.

Good computational skills.

Good knowledge of a range of MIDD software (R NONMEM STAN etc.).

Good communication skills (written oral presentation).

Competency

Pharmacometrics: demonstrates thorough understanding and application of quantitative modeling and simulation principles.

Communication Skills: demonstrates excellent verbal and written communication skills.

Organizational Relationships:

Reports to Pharmacometrics Group Leader or Head of Pharmacometrics and Systems Pharmacology within the line organization of Pharmacometrics and Systems Pharmacology Translational Clinical Sciences.

Matrixed relationships particularly with Clinical Pharmacology Leads QSP modelers Clinicians Statisticians and colleagues from Pharmacokinetics Dynamics and Metabolism (PDM) and other groups as required.

Work Location Assignment:Hybrid

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Relocation assistance may be available based on business needs and/or eligibility.